510(k) · Cleared
ClearedDESCRIBE PFD Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merz North America, Inc. · PKO Transparent Patch For Use In Treatment Of Tattoos
Cleared on Nov 29, 2017 as substantially equivalent to K150212 (On Light Sciences, Inc., 2015) after an 84-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Nov 29, 2017
- Review
- 84 days
- Class
- Class II
- Product code
- PKO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K950019 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −1 | K150212 | DeScribe Transparent PFD Patch | On Light Sciences, Inc. | 2015 | — |
| 0 (this device) | K172689 | DESCRIBE PFD Patch | Merz North America, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PKO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K150212 | DeScribe Transparent PFD PatchSummary page 4…and in dermatology Regulation: 21 C.F.R. § 878.4810 Product Code: PKO Classification Panel: General and Plastic Surgery Predicate Device: DeScribe Transparent PFD Patch (K150212) Indications for Use: The DESCRIBE PFD Patch is indicated for use as an accessory to laser tattoo removal procedures usi… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 20.0 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K150212.
How does its category compare?
All PKO devicesPKO Transparent Patch For Use In Treatment Of Tattoos: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PKO
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · PKO
Too few PKO 510(k)s in any year since 2007 to give a median.
Recalls per year · PKO
No recall names PKO since 2007.
Adverse event reports per year · PKO
1in 2025
MAUDE reports naming product code PKO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DESCRIBE PFD Patch is indicated for use as an accessory to laser tattoo removal procedures using 532, 694, 755, and 1064 nm standard Q-Switched (QS) lasers and 532, 755, 785, and 1064 nm standard picosecond lasers in Fitzpatrick Skin Type I-Ill patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172689 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172689: DESCRIBE PFD Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172689
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026